Helicobacter Test INFAI

Medicinal product

(Invented) name

Helicobacter Test INFAI

Active substance (s)

(13)C-karbamidas

Strength

75 mg

Pharmaceutical form

milteliai geriamajam tirpalui

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

V04CX, Other diagnostic agents

Marketing authorisation holder

INFAI GmbH, Vokietija

Date of authorisation

1997-08-14

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

powder for oral solution	1 vnt.
(13)C-karbamidas	75 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
26133	28722	1028722	plačiakaklis indas	N1 (+ 4 bandinių buteliukai)		Receptinis	EU/1/97/045/001	Netiekiama	-	-	No	-	-
26134	28723	1028723	plačiakaklis indas	N1 (+ 2 iškvepiamo oro maišeliai)		Receptinis	EU/1/97/045/002	Netiekiama	-	-	No	-	-
26135	28724	1028724	plačiakaklis indas	N50 (+ 50 iškvepiamo oro maišelių)		Receptinis	EU/1/97/045/004	Netiekiama	-	-	No	-	-
57117	71231	1071231	plačiakaklis indas	N50		Receptinis	EU/1/97/045/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
1997-08-14	Registruotas